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Zoll Battery Li-Ion

FDA UDI

Class III (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
ZOLL BATTERY LI-ION FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Model / Reference
1008-002003-01 FDA UDI

Identifiers

Primary DI / UDI-DI
00847946016821 FDA UDI
510(k) Number
K110526 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Rechargeable professional automated external defibrillator FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rechargeable professional automated external defibrillator

Zoll Battery Li-Ion by Zoll Medical Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rechargeable professional automated external defibrillator.

Cleared under the same submission

K110526 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zoll Medical Corporation

Sources (1)

  • FDA UDI 168b8cbe-984b-4d1e-b2a3-e322136ac2f2 34 fields · synced Jun 8, 2026